MYSILDECARD 20 мг Фильм-coated таблетки

Содержание инструкции

1. Mysildecard 20 mg film-coated tablets
   1. What is Mysildecard and what is it used for
   2. What you need to know before taking Mysildecard
   3. How to take Mysildecard
   4. Possible side effects
   5. How to store Mysildecard
   6. Package contents and other information

Mysildecard 20 mg film-coated tablets

sildenafil

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Mysildecard is and what it is used for
• 2. What you need to know before you take Mysildecard
• 3. How to take Mysildecard
• 4. Possible side effects
• 5. How to store Mysildecard
• 6. Contents of the pack and other information

1. What is Mysildecard and what is it used for

Mysildecard contains the active ingredient sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Mysildecard reduces blood pressure in the blood vessels of the lungs by dilating the pulmonary blood vessels.
Mysildecard is used for the treatment of adults and children and adolescents from 1 to 17 years with high
blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

2. What you need to know before taking Mysildecard

Do not take Mysildecard
if you are allergic to sildenafil or any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines that contain nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrate (“poppers”). These medicines are often
used to treat chest pain attacks (or “angina pectoris”). Mysildecard may
cause a considerable increase in the effects of these medicines. Tell your doctor if you are
taking any of these medicines. If you have any doubts, consult your doctor or
pharmacist.
if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that PDE5 inhibitors, such as sildenafil, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you have any doubts, tell your
doctor.
if you have recently had a stroke, a heart attack or if you have had a serious liver disease or very low blood pressure (< 90/50 mmHg).
if you are taking a medicine to treat fungal infections, such as ketoconazole
or itraconazole or medicines containing ritonavir (for HIV).
if you have previously had vision loss caused by a problem with blood flow to the
eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Mysildecard if:
the disease is due to obstruction or narrowing of a pulmonary vein rather than an
artery.
you have a serious heart problem.
you have problems with the heart ventricles.
you have high blood pressure in the blood vessels of the lungs.
you have low blood pressure while at rest.
you are losing large amounts of body fluids (dehydration), which can happen when you sweat
a lot or when you don't drink enough fluids. This can happen if you are sick with fever,
vomiting or diarrhea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of the red blood cells (sickle cell anemia), a cancer of the blood cells
(leukemia), a cancer of the bone marrow (multiple myeloma) or any disease or deformity of the
penis.
you currently have a stomach ulcer, a bleeding disorder (such as hemophilia) or
problems with nosebleeds.
you are taking medicines for erectile dysfunction.
When it has been used for the treatment of erectile dysfunction (ED), with PDE5 inhibitors, including sildenafil, the following adverse effects on vision have been reported, with unknown frequency: partial, sudden, temporary or permanent reduction or loss of vision in one
or both eyes.
If you experience a sudden decrease or loss of vision, stop taking
Mysildecard and contact your doctor immediately(see also section 4).
Prolonged and sometimes painful erections have been reported after taking sildenafil in men. If you have an erection that lasts continuously for more than 4 hours, stop
taking Mysildecard and contact your doctor immediately(see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you should tell your doctor because a
dose adjustment may be necessary.

Children
Mysildecard should not be given to children under 1 year of age.

Other medicines and Mysildecard
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Medicines that contain nitrates or substances that release nitric oxide, such as amyl
nitrate (“poppers”). These medicines are often used to treat angina pectoris or “chest pain” (see section 2. What you need to know before taking
Mysildecard).
Tell your doctor or pharmacist if you are already taking riociguat (see section 2).
Therapies for pulmonary arterial hypertension (for example bosentan, iloprost).
Medicines containing St. John's Wort (herbal medicine), rifampicin
(used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (also used for
epilepsy).
Medicines that inhibit blood clotting (for example warfarin), although no adverse effects have been reported.
Medicines containing erythromycin, clarithromycin, telithromycin (are antibiotics used to
treat some bacterial infections), saquinavir (for HIV) or nefazodone (for depression),
because a dose adjustment may be necessary.
Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or
prostate problems, as the combination of the two medicines may cause symptoms that
lead to low blood pressure (e.g. dizziness, lightheadedness).
Medicines containing sacubitril/valsartan, used to treat heart failure.

Mysildecard with food and drink
Do not drink grapefruit juice while being treated with Mysildecard.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Mysildecard
should not be taken during pregnancy unless absolutely necessary.
Mysildecard should not be given to women of childbearing potential unless they use adequate
contraceptive methods.
Mysildecard passes into breast milk in small amounts and is not thought to be harmful to
the baby.

Driving and using machines
Mysildecard can cause dizziness and can alter vision. Before driving and using machines
you should be aware of how you react to this medicine.

Mysildecard contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially
“sodium-free”.

3. How to take Mysildecard

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (to be taken at intervals of 6-8 hours) with
or without food.

Use in children and adolescents
For children and adolescents from 1 to 17 years of age, the recommended dose is 10 mg three times a day
for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents
> 20 kg, to be taken with or without food. Higher doses should not be used in children. This
medicine should only be used if a 20 mg three times a day dosage is appropriate. Other
pharmaceutical forms may be more appropriate for administering to patients weighing ≤
20 kg and to other younger patients who are unable to swallow the tablets.

If you take more Mysildecard than you should
You should not take a quantity of medicine greater than that prescribed by
your doctor.
If you take a quantity of medicine greater than that prescribed, contact your doctor
immediately. Taking more Mysildecard than you should could increase the risk of known
side effects.

If you forget to take Mysildecard
If you forget to take Mysildecard, take the dose as soon as you remember and then continue to
take the medicine at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Mysildecard
Suddenly stopping treatment with Mysildecard can lead to a worsening of
symptoms. Do not stop treatment with Mysildecard unless your doctor decides to. Your doctor
may tell you to reduce the dose over a few days before stopping treatment completely.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you must stop taking
Mysildecard and contact your doctor immediately (see also section 2):

• if you experience sudden vision impairment or loss of vision (frequency not known)
• if you have an erection that persists continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported, with frequency not known.

Adults
Very common side effects (may affect more than 1 in 10 people) have been headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Common side effects (may affect up to 1 in 10 people) include:
skin infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia),
fluid retention, sleep disorders, anxiety, headache, tremor, pins and needles sensation,
burning sensation, reduced sense of touch, bleeding in the back of the eye, effects
on vision, blurred vision and sensitivity to light, effects on colour perception,
eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds,
increased nasal secretions, cough, nasal congestion, stomach inflammation, gastroenteritis,
heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss,
skin redness, night sweats, muscle pain, back pain and increased body temperature.
Uncommon side effects (may affect up to 1 in 100 people) reported include: reduced visual acuity, double vision, abnormal sensation in the eye,
penile bleeding, blood in semen and/or urine, and excessive development of male breast tissue.
Skin rash, a sudden decrease or loss of hearing and
decreased blood pressure have also been reported, with frequency not known (the frequency cannot be established from the available data).
Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in 10): pneumonia, heart failure, right-sided heart failure, heart-related shock,
high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis,
viral infection of the stomach and intestines, urinary tract infection and tooth decay.
The following serious adverse events have been considered treatment-related and have been reported uncommonly (may affect up to 1 in 100): allergic reactions (such as skin rash,
swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsions,
irregular heartbeat, hearing loss, shortness of breath, inflammation of the digestive tract,
wheezing due to breathing problems.
Very common side effects (may affect more than 1 in 10 people) have been:
headache, vomiting, sore throat, fever, diarrhoea, influenza and nosebleeds.
Common side effects (may affect up to 1 person in 10) have been:
nausea, increased erections, pneumonia and runny nose.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mysildecard

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging, after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mysildecard contains
The active ingredient is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The excipients are:
Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate, sodium
croscarmellose (see section 2 “Mysildecard contains sodium ”)and magnesium stearate.
Film coating: hypromellose (6mPas), titanium dioxide (E171) and triacetin.

Description of the appearance of Mysildecard and contents of the pack
Mysildecard tablets are white, film-coated and have a round shape. The
tablets have M imprinted on one side and SL above 20 on the other side. The tablets are available in
blisters containing 90, 300 and (90 x 1) tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer:
Mylan Hungary Kft.
Mylan utca 1,
Komárom,
2900,
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

Lietuva
UAB GL Pharma Vilnius
Tel.: +370 5 261 0705

België/Belgique/Belgien
Mylan bvba/sprl
Tél/Tel: + 32 02 658 61 00

Luxembourg/Luxemburg
Mylan bvba/sprl
Tél/Tel: + 32 02 658 61 00
(Belgique/Belgien)

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Magyarország
Mylan EPD Kft
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Česká republika
Viatris CZ s.r.o
Tel: + 420 222 004 400

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
G.L. Pharma Eesti OÜ
Tel.: +372 50 87 043

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Generics Pharma Hellas ΕΠΕ
Τηλ: +30 210 993 6410

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

Polska
Mylan Healthcare Sp. z.o.o.
Tel.: + 48 22 546 64 00

España
Viatris Pharmaceuticals, S.L.U.
Tel: + 34 900 102 712

France
Substipharm
Tél: +33 1 43181300

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 56

Hrvatska
Mylan Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
Aurobindo Pharma Romania SRL
Tel: 004021 361 1011

Slovenija
Mylan Healthcare d.o.o.
Tel: + 386 1 23 63 180

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Mylan Italia S.r.l
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Sverige
Viatris AB
Tel: + 46(0)8 630 19 00

Κύπρος
Varnavas Hadjipanayis Ltd
Τηλ: +357 2220 7700

Latvija
SIA G.L. Pharma Riga
Tel: +371 67887140

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu/. Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.
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